The LTC Innovation Blog

Compliance is the foundation of safe, effective pharmacy operations in long-term care (LTC) settings. The regulatory landscape is complex, with strict oversight designed to protect patients and ensure proper medication management. Failure to comply can lead to severe consequences—fines, legal action, reputational damage, and (most importantly) harm to residents who rely on accurate and timely medication delivery.

Decoding the Decline in Reimbursements By Mark Fulton, PharmD, MBA, BCNSP, NSC-II

In July 2023, several pharmacy organizations (NABP, APhA, NACDS) sent a joint letter to the Food and Drug Administration (FDA). The letter asked the FDA to use its authority to delay the final implementation deadline for the Drug Supply Chain Security Act (DSCSA) until February 2026. The FDA responded to this request with an announcement on 8/25/23 that the effective date for full implementation of the DSCSA will be delayed for one year, becoming effective and enforceable on 11/27/24.

The United States Pharmacopeia (USP) Chapter <800> standards for hazardous drug handling will become effective and enforceable on November 1, 2023. This move coincides with the official implementation of the USP <795> and <797> standards for non-sterile and sterile compounding. USP <800> has been delayed from its original intended implementation date to align with corresponding references to the <795> and <797> chapters.

Summary: This article delves into the upcoming updates in the United States Pharmacopoeia (USP) chapters <795> and <797>, effective November 1, 2023.